Microplastic risk in Zyn pouches: Scientist questions FDA approval | STAT

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Former FDA scientist Christy Leppanen says the agency approved Zyn nicotine pouches for sale without fully understanding what they’re made of.Leila Navidi for The Examination

Health

FDA authorized Zyn nicotine pouches without knowing what they were made of, says former agency scientist

Toxicologist says agency failed to consider whether the pouch material could shed microplastics

By Matthew Chapman and Kathryn Kranhold — The Examination<br>July 14, 2026

This story is published in partnership with The Examination.

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Four years into the U.S. Food and Drug Administration’s review of Zyn nicotine pouches, and not long before the agency approved them for sale, an FDA toxicologist ran some informal tests in her kitchen that led her to question whether the agency truly understood the addictive product it was about to green-light.

Christy Leppanen worked for the FDA’s Center for Tobacco Products, where she led a project examining the potential for microplastics exposure. A scientist who had worked on an environmental assessment of Zyn had repeatedly told her that the nicotine pouches melt in the mouth. But during a public health conference in late 2024, Leppanen said, she talked to an academic who reinforced her understanding that they don’t.<br>Advertisement

The FDA allowed stores to sell Zyn while it evaluated the product. On the way home from the conference, Leppanen said, she went to the Mall of America, bought a can of menthol-flavored Zyn, and took it home. She put the pouches in her mouth. She soaked them in a cup with saliva. She heated them in the microwave, crushed them, and sucked them. They did not dissolve.

Over the course of the next several weeks, Leppanen said, she pushed her colleagues to consider possible health and environmental risks from the pouch material. She was repeatedly rebuffed.

Now she has accused the FDA of authorizing one of the fastest-growing nicotine products in America without knowing what the pouch itself is made of.<br>Advertisement

In interviews, emails to federal officials, and recordings reviewed by The Examination, Leppanen has alleged that the FDA lacked critical facts about the material of Zyn pouches, decided not to seek additional information from the manufacturer, Philip Morris International, and nevertheless concluded the material was unlikely to harm consumers.

“Fundamentally, we did not do a proper assessment,” Leppanen said. “People believe the FDA is doing more than it is.”

To top it off, when the FDA announced its approval of Zyn, it published a document saying Leppanen had signed off on the environmental review — a mistake that the agency quickly acknowledged but didn’t publicly correct for months.

Leppanen and several scientists told The Examination that the pouches could shed tiny particles during use, which could be absorbed by users. Research on microplastics indicates they accumulate in human organs, and evidence is emerging that this could be harmful.

“With the increasing body of information about microplastics exposure and how they cross into the bloodstream from the gut, we just needed to know what those materials are,” Leppanen said.

The tobacco industry is championing pouches and e-cigarettes, which contain nicotine and flavorings, because they deliver a buzz without inhaling harmful cigarette smoke. The U.S. market for nicotine pouches is estimated to increase by 37% this year to $6.8 billion, according to the market research firm TobaccoIntelligence.

New nicotine products such as pouches and vapes must be authorized for sale by the FDA, which examines whether they are “appropriate for the protection of public health.” The agency weighs the potential harm to public health, such as young nonsmokers using these addictive products, against the potential benefit: helping adult smokers move away from cigarettes.

Two former senior FDA officials told The Examination that this review should address the pouch material. They and another...